Fluid dispenser with fill adapter

ABSTRACT

An elastomeric bladder stored energy type infusion apparatus which includes a unique fill assembly for use in controllably filling the fluid reservoir of the dispenser portion of the apparatus. The filling assembly includes a prefilled vial which is partially received within a novel adapter assembly that functions to operably couple the prefilled vial with the fluid dispenser subassembly of the apparatus. The body of the prefilled vial is surrounded by a protective covering until immediately prior to mating the assembly with the fluid delivery device.

This is a Continuation-In-Part Application of U.S. application Ser. No.08/577,496 filed Dec. 22, 1995, now U.S. Pat. No. 5,700,244 which is aContinuation-In-Part of application Ser. No. 08/192,031 filed on Feb. 3,1994 entitled Fluid Dispensing Apparatus and issued into U.S. Pat. No.5,484,415; which is a Continuation-In-Part of U.S. application Ser. No.08/156,685 filed on Nov. 22, 1993 and has now issued into U.S. Pat. No.5,433,709 entitled Fluid Dispenser; which is a Continuation-In-Part ofSer. No. 08/053,723 filed Apr. 26, 1993 and has now issued into U.S.Pat. No. 5,354,278; which is a Continuation-In-Part application of Ser.No. 07/870,521 filed on Apr. 17, 1992 and now issued into U.S. Pat. No.5,263,940.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to infusion devices. Moreparticularly, the invention concerns an elastomeric bladder typeinfusion apparatus which is used for delivering a beneficial agent to apatient at a substantially constant rate. The apparatus uniquelyincludes a fluid dispensing assembly and a novel fill assembly which canbe interconnected with the dispensing assembly for filling the fluidreservoir thereof in the field prior to use.

2. Discussion of the Invention

Many types of infusion pumps embodying an elastomeric balloon or bladderfor delivery of a quantity of pharmaceutically active material to apatient have been suggested in the past. For example, U.S. Pat. No.4,915,693 issued to Hessel discloses an infusion pump comprising anelastomeric bladder having at least an open end, and an elongate stressmember extending concentrically within the entire length of the hollowportion of the bladder and having a fluid tight seal therewith. Both afilling port and an exit port are provided in the stress member, each influid communication with the interior of the bladder by way of aninfluent and an effluent lumen, respectively. The stress member has adiameter that is greater than the relaxed internal diameter of thebladder, and has a length that exceeds the relaxed internal length ofthe hollow portion of the bladder, so that it prestresses the bladder inboth the axial and radial directions when disposed therein,substantially filling the bladder in its unfilled state. The Hesseldevice also includes a one-way valve on the stress member which permitsflow in the influent lumen only in the direction of the interior of thebladder.

Another type of balloon type infusion device is disclosed in U.S. Pat.No. 4,386,929 issued to Perry, et al. The Perry, et al. device hasspaced apart inlet and outlet means and the bladder which is capable ofexpanding and contracting radially and axially upon inflation anddeflation. When deflated the lumen of the bladder is substantiallycompletely filled by lumen filling means which protect the bladder frombeing punctured by the hypodermic needle used to fill and inflate thebladder. The lumen filling means resists the compressive load appliedduring insertion of the needle and maintains the inlet and outlet meansin spaced apart relationship while providing substantially no resistanceto the axial expansion of the bladder. By having the lumen of thebladder filled with the lumen filling means when the bladder isdeflated, before its subsequent inflation and deflation, substantiallycomplete expulsion of the fluid contents of the bladder can be obtained.

Very early balloon type infusion devices are described in U.S. Pat. Nos.3,468,308 and 3,469,578 issued to Bierman. These patents disclose adevice for expelling a liquid from a bladder member at an extremely slowrate over an extended period of time. In the device described in U.S.Pat. No. 3,469,578, the liquid is expelled solely by pressure induced onthe liquid by the internal stresses of the distended bladder member. Inthe device disclosed in U.S. Pat. No. 3,468,308, the liquid is expelledby pressure control means which controls pressure applied to theexterior of the bladder member to control its rate of collapse.

In the devices described in both of the aforementioned patents, thebladder member comprises a balloon, or tube-like member which istypically distendable both lengthwise and laterally when initiallypressured. Admission and discharge of liquid is of necessity, through asingle neck, or outlet portion of the balloon-like bladder.

None of the prior art devices known to applicant include the unique fillassembly of the present invention which can be used to controllably fillthe fluid reservoir of the fluid dispenser portion of the invention inthe field. As will be better understood from the description whichfollows, the fill assembly of the present invention includes a fluidcontaining vial assembly mounted within a unique adapter assembly whichfunctions to conveniently mate the vial assembly with the fluiddispenser portion of the apparatus to enable expeditious filling of thefluid reservoir thereof. Co-pending application, Ser. No. 08/192,031describes in detail the construction of several types of elastomericbladder stored energy type infusion devices of a character similar tothe fluid dispenser portion of the apparatus described herein. Theapparatus of the present invention comprises an improvement of thesedevices and accordingly application, Ser. No. 08/192,031, is herebyincorporated by reference in its entirety as though fully set forthherein.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide an elastomericbladder stored energy type infusion apparatus which includes a uniquefill assembly for use in controllably filling the fluid reservoir of thedispenser portion of the apparatus.

Another object of the present invention is to provide an apparatus ofthe aforementioned character in which the fill assembly comprises a vialassembly of generally conventional construction that can be prefilledwith a wide variety of medicinal fluids.

Another object of the present invention is to provide a fill assembly ofthe type described in the preceding paragraph in which the prefilledvial assembly is partially received within a novel adapter assembly thatfunctions to operably couple the vial assembly with the fluid dispensersubassembly of the apparatus.

Another object of the invention is to provide an adapter assembly of thetype described in which the body of the prefilled vial is surrounded bya protective covering until immediately prior to mating the assemblywith the fluid delivery device.

Another object of the invention is to provide an apparatus as describedin the preceding paragraphs in which the adapter assembly includeslocking means for locking the assembly to the fluid delivery assemblyfollowing filling of the fluid reservoir thereof.

Another object of the invention is to provide a novel adapter assemblyfor use with the bladder type stored energy fluid dispenser subassemblyof the apparatus which is easy to use, is inexpensive to manufacture,and one which maintains the prefilled vial in an aseptic condition untiltime of use.

Other objects of the invention are set forth in Ser. No. 08/192,031which is incorporated herein by reference and in Ser. No. 08/053,723which is, in turn, incorporated by reference in U.S. Ser. No.08/192,031.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a generally perspective exploded view of one form of the fluiddelivery apparatus of the present invention showing the fluid dispenserassembly and the fill assembly of the apparatus as they appear prior tomating the fill assembly with the dispenser assembly.

FIG. 2 is a generally perspective, exploded view of the apparatus shownin FIG. 1.

FIG. 3 is a right end view of the apparatus of FIG. 1.

FIG. 4 is an enlarged, cross-sectional view taken along lines 4--4 ofFIG. 3.

FIG. 5 is a view, partly in cross section, taken along lines 5--5 ofFIG. 4.

FIG. 6 is a generally perspective, exploded view of one form of the fillassembly of the present invention.

FIG. 7 is an enlarged cross-sectional view of the fill assemblyillustrated in FIG. 6 as it appears in an assembled configuration.

FIG. 8 is a cross-sectional view similar to FIG. 7, but showing theappearance of the component parts of the invention after the plunger ofthe container has been telescopically moved from a first to a secondposition.

FIG. 9 is an enlarged, cross-sectional view taken along lines 9--9 ofFIG. 7.

FIG. 10 is an enlarged, cross-sectional view of the adapter subassemblyreceiving chamber of an alternate form of the apparatus which embodies ablunt cannula rather than a needle type cannula and showing the adaptersubassembly partially inserted into the receiving chamber.

FIG. 11 is an exploded, cross-sectional view of an alternate form of thefluid dispenser assembly of the apparatus of the invention.

FIG. 12 is an enlarged view taken along lines 12--12 of FIG. 11.

FIG. 13 is an enlarged view taken along lines 13--13 of FIG. 11.

FIG. 14 is an enlarged view taken along lines 14--14 of FIG. 11.

FIG. 15 is an enlarged, cross-sectional view of the fully assembleddispenser portion of the apparatus shown in FIG. 11 operably coupledwith the fill assembly of the apparatus of the invention.

FIG. 16 is an exploded, cross-sectional view of the forward portion ofstill another form of fluid dispenser assembly of the present invention.

FIG. 17 is a view taken along lines 17--17 of FIG. 16.

FIG. 18 is a view taken along lines 18--18 of FIG. 16.

FIG. 19 is a view taken along lines 19--19 of FIG. 16.

FIG. 20 is a view taken along lines 20--20 of FIG. 16.

FIG. 21 is a cross-sectional view of the forward portion of the fluiddelivery assembly shown in FIG. 16 as it appears with the variouscomponents thereof assembled together.

FIG. 22 is a cross-sectional view taken along lines 22--22 of FIG. 21.

FIG. 23 is a generally perspective, exploded view of another form of theapparatus of the present invention.

FIG. 24 is an enlarged, side elevational view of the assembled apparatusshown in FIG. 23.

FIG. 25 is a cross-sectional view taken along lines 25--25 of FIG. 24.

FIG. 26 is a cross-sectional view taken along lines 26--26 of FIG. 25.

FIG. 27 is a cross-sectional view taken along lines 27--27 of FIG. 25.

FIG. 28 is a cross-sectional view taken along lines 28--28 of FIG. 25.

FIG. 29 is an enlarged, fragmentary, cross-sectional view of a portionof the apparatus shown in FIG. 25 illustrating the position of theplunger following the fluid dispensing step.

DESCRIPTION OF ONE FORM OF THE INVENTION

Referring to the drawings and particularly to FIGS. 1 through 9, oneform of the fluid dispenser apparatus of the present invention is thereillustrated and generally identified by a numeral 10. Apparatus 10comprises two main assemblies, namely a fluid dispensing assembly 11 anda fill assembly 12 for use in filling the fluid reservoir of thedispensing assembly. Dispensing assembly 11, the details of constructionof which will presently be described, is similar in many respects to thedispenser described in Ser. No. 08/192,031 and includes a tubularsupport, a stored energy means for forming in conjunction with thesupport a fluid reservoir for containing medicinal fluids to becontrollably infused into a patient and a generally cylindrically shapedhousing which circumscribes the tubular support and stored energy means.

As best seen by referring to FIGS. 2 and 6, the fill assembly portion 12of the apparatus comprises a container subassembly 14, an adaptersubassembly 15, and a cover subassembly 17, the character of which willpresently be described. Container subassembly 14 includes a body portion16, having a fluid chamber 18 for containing an injectable fluid "F"provided with first and second open ends 20 and 22 (FIGS. 7 and 8).First open end 20 is sealably closed by closure means here provided inthe form of a pierceable septum assembly 24. Septum assembly 24 is heldsecurely in position by clamping ring 24a. As best seen in FIGS. 7 and8, a plunger 26 is telescopically movable within chamber 18 of containersubassembly 14 from a first location shown in FIG. 7 where it isproximate first open end 22 to a second position shown in FIG. 8 whereit is proximate first open end 20. The vial portion of the containersubassembly 14 can be constructed of various materials such as glass andplastic.

Referring particularly to FIG. 6, it can be seen that the adaptersubassembly 15 comprises a hollow housing 30 having a first open end 32and a second closed end 34 (FIG. 8). Container subassembly 14 istelescopically receivable within open end 32 of housing 30 in the mannershown in FIG. 7 so that the housing can be moved from the first extendedposition shown in FIG. 7 to the vial encapsulation position shown inFIG. 8. Forming an important part of the adapter subassembly is pushermeans shown here as an elongated pusher rod 36 which functions to moveplunger 26 within fluid chamber 18 from the first position shown in FIG.7 to the second position shown in FIG. 8. In the form of the inventionshown in the drawings, pusher rod 36 has a first end 36a interconnectedwith closure wall 34 and an opposite end 36b which engages plunger 26and causes telescopic movement of the plunger within chamber 18 ofcontainer subassembly 14 as housing 30 is moved from the extendedposition into the vial encapsulating position shown in FIG. 8.

As best seen by referring to FIG. 9, the interior wall 31 of housing 30is provided with circumferentially spaced-apart protuberances 40 whichengage and center container subassembly 14 within housing 30. Due to thesmall surface area presented by protuberances 40, there is littlefrictional resistance to the sliding movement of container subassembly14 relative to housing 30 as the housing is moved from the extendedposition shown in FIG. 7 into the vial encapsulating position shown inFIG. 8.

Referring to FIG. 6, it is to be noted that cover subassembly 17 of thefill assembly of the present form of the invention includes a spiralwound, frangible portion 42 having a first open end 44 fortelescopically receiving body portion 16 of container subassembly 14(FIG. 7) and a second closed end 46. Portion 42 initially circumscribesa major portion of container subassembly 14 in the manner best seen inFIG. 7. An integral pull tab 42a is provided to permit the spiral wound,frangible portion to be pulled from container subassembly 14 so as toexpose a substantial portion of body 16. As best seen in FIG. 6, amedicament label 50 circumscribes spiral wound portion 42 and serves toprevent accidental unwinding of the spiral portion from the containersubassembly 14. However, upon pulling tab 42a, the spiral portion willunwind and, in so doing, will tear medicament label 50 so that thespiral portion 42 of the covering as well as the cylindrical portion 52which, also comprises a part of the cover assembly, can be slipped fromthe container 14 so as to expose to view septum assembly 24.

As shown in FIGS. 6 and 7, apertured end 52a of cylindrical portion 52of subassembly 17 is provided with venting apertures 54 which arecovered by a porous vent patch 56 which can be constructed from anysuitable porous material that will permit air entrapped within theinterior of subassembly cover subassembly 17 to be expelled toatmosphere as the subassembly is placed over container subassembly 14.

Turning once again to FIGS. 2 through 5, the fluid dispensing assembly11 of the apparatus of the invention can be seen to comprise anelongated housing 60 having an internal chamber 62 and a support 64disposed within internal chamber 62 and extending longitudinallythereof. The stored energy means of the invention is here provided inthe form of a generally cylindrically shaped, elongated elastomericmember 66. Housing 60 includes a generally cylindrically shaped centralportion 60a and inlet and outlet end plates 60b and 60c respectively.Central section 60a and end plates 60b and 60c may be constructed fromany suitable rigid plastic material such as a polycarbonate and the endplates can be affixed to the central section by any suitable means suchas adhesive bonding or an appropriate sonic weldment. Elastomeric member66 is securely affixed proximate its ends to a two-part support 64 (FIG.4) by means of suitable ring clamps 68 and 70 such as self-lockingplastic panduit strips of the character shown in FIG. 2.

As best seen by referring to FIG. 4, support 64 is provided with anelongated receiving chamber 82 having an inner end wall portion 84 withsupports a hollow piercing cannula 86 which extends into receivingchamber 82. Wall 84 is provided with first and second radially extendingfluid passageways 90 and 92. Passageway 90 communicates proximate itscentral portion with the fluid passageway of hollow cannula 86 andcommunicates at its extremities with a fluid reservoir 94 formed betweenelastomeric member 66 and the outer central surface of support 64. Theextremities of passageway 92 also communicate with fluid reservoir 94,while the center of the passageway communicates with a longitudinallyextending outlet passageway 96, which, in turn, communicates with flowcontrol means 97, the character of which will presently be described.End plate 60c is provided with an outlet passageway 100 which is incommunication with the flow control means 97 and forms a part of luerconnector like construction 102 which is integrally formed with endplate 60c.

The novel flow control means of the form of the invention shown in FIG.4 comprises an assemblage made up of three disc-like wafers which aremounted proximate the ends of a rate control chamber 104 formed in acylindrical extension 105 of the end plate 60c. Wafers 106 and 108 ofthe assemblage comprise porous glass distribution frits of a characterwell known in the art, while intermediate wafer 110 comprises a filtermember. A rate control assemblage, generally designated by the numeral112, is disposed between glass frit 106 and filter member 110.

Filter member 110 can be constructed from a wide variety of materials,but a material comprising polysulfone sold by Gelman Sciences under thename and style of SUPOR has proven satisfactory for the purpose. Ratecontrol assemblage 112 is preferably constructed from a porous materialhaving small flow apertures which controllably impede fluid flow.However, a number of other materials can also be used to construct thispermeable member including metals, ceramics, cermet, plastics and glass.The rate control member can be specifically tailored to accommodate veryspecific very specific delivery regimes including very low flow andintermediate flow conditions. Such rate control assemblages are wellknown by those skilled in the art.

In using the apparatus of the invention, with the fill assembly in thefilled configuration shown in FIG. 7, the cover subassembly is firstremoved from the container subassembly by pulling on pull-tab 42a. Thiswill cause the spiral portion 42 of the cover subassembly to tear awayfrom the container subassembly so that it can be separated from theforwardly disposed portion 52. Once the spiral wound portion 42 isremoved, cylindrical portion 52 can also be removed and discarded.Removal of the cover subassembly exposes the forward portion of thecontainer subassembly and readies the adapter subassembly forinterconnection with the fluid dispensing assembly 11.

Mating of the adapter subassembly 15 with the dispensing assembly 11 isaccomplished by telescopically inserting the exposed container portionof the container subassembly 14 into receiving chamber 82 and pushingthe assemblage forwardly of housing 60. As the adapter subassemblyapproaches a seated position within receiving chamber 82, the piercingcannula 86 connected to end portion 64 will pierce septum assembly 24 ofthe container subassembly. Once the fluid flow path between the hollowcannula and the fluid reservoir 94 of the fluid dispensing device isthus created via passageway 90, a continued inward movement of theadapter subassembly 15 will cause pusher rod 36 thereof to move plunger26 forwardly of chamber 18 to a position shown in FIG. 4. As plunger 26is moved forwardly of chamber 18, fluid contained within the chamberwill flow through the hollow cannula into passageway 90 of partitionwall 84 and then into fluid reservoir 94. As the fluid under pressureflows into reservoir 82, membrane 66 will be distended outwardly in themanner shown in FIG. 4 wherein the central portion thereof is spacedfrom support 64. Rings 68 and 70, which are in clamping engagement withsupport 64 function to seal the membrane against the end portions of thesupport and prevent leakage of fluid between the membrane and thesupport. As the distendable membrane expands outwardly, the displacedair within housing 60 will be vented to atmosphere via vent means "V"provided in end plate 60b.

It is to be understood that membrane 66 can comprise a single film layeror can be made up of a laminate construction comprising of a number ofcooperating layers of material. Materials suitable for constructingmembrane 66 include latex rubber, polyisoprene (natural rubber), butylrubber, nitrile rubber, other homopolymer, copolymers (random,alternating, block, graft, crosslink and starblock), mechanical polyblends and interpenetrating polymer networks.

Once distendable membrane 66 is distended to form fluid reservoir 94,the apparatus will remain in this filled condition until outletpassageway 100 of the luer like connector assembly 102 is opened by theremoval of a suitable closure cap 103 of the character shown by thephantom lines in FIG. 4. With outlet passageway 100 opened, the storedenergy means or membrane 66 will tend to return to a less distendedcondition causing fluid to flow outwardly of the apparatus viapassageway 92, passageway 96, through the flow control means 97, andthen through passageway 100.

Materials suitable for use in constructing housing 60 and support 64include metals, rubber or plastics that are compatible with the liquidsthey contact and are preferably non-allergenic type material. Examplesof such materials are: stainless steel, aluminum, latex rubber, butylrubber, nitrile rubber, polyisiprene, styrene-butadiene copolymer,silicones, polyolefins such as polypropylene and polyethylene,polyesters, polyurethane, polyamides and polycarbonates. Manufactures ofsuitable materials for use in constructing the fluid dispensing assemblyof the invention include: Dow Corning of Midland, Mich.; GeneralElectric of Schenectady, N.Y.; and Shell Chemical Company of Houston,Texas; DuPont Chemical of Wilmington, Del.; and Eastman Chemical ofKingsport, Tenn.

In order to securely lock the adapter subassembly with the dispensingassembly 11 after the reservoir has been filled, novel locking means areprovided. The locking means here comprise a series of locking teeth 122and 124 respectively. As indicated in FIG. 4, these locking teeth areconstructed so that they will slide under a flexible locking tab 126,which is provided proximate the entrance of receiving chamber 82, as theadapter subassembly is urged inwardly of receiving chamber 82. However,once the adapter subassembly has reached the fully forward positionshown in FIG. 4, locking tab 126 will engage one of the teeth 124 andeffectively prevent removal of housing 60 of the adapter subassemblyfrom passageway 82. With this novel construction, once the reservoir 94has been filled with the fluid "F" contained in the containersubassembly, the adapter assembly cannot be removed from the fluiddispensing device and, thereby preventing system adulteration.

Turning to FIG. 10 another form of the apparatus of the invention isthere shown. This apparatus is similar in construction and operation tothat shown in FIG. 1 through 9 save that the septum of container septumassembly, designated in FIG. 10 as 25, is a slit septum and the cannula,designated in FIG. 10 as 86a, is a blunt cannula configuration. Suchconstructions are well known to those skilled in the art and can be usedin lieu of conventional non-coring pierceable septums and sharp needles.The blunt cannula type device partially shown in FIG. 10 operates in thesame manner as the apparatus of FIGS. 1 through 9.

Referring next to FIGS. 11 through 15, still another embodiment of thepresent invention is there illustrated. This embodiment is also similarin many respects to the embodiment shown in FIGS. 1 through 9 and,accordingly, like numbers have been used to identify like components.The primary difference between this latest form of the invention andthat previously described herein is the provision of an alternate fillmeans for filling the reservoir of the device. Forming a part of thisnovel alternate fill means are strategically located valve means whichare disposed within the dispensing assembly for controlling fluid flowthrough the apparatus. As will become apparent from the discussion thatfollows, this novel valve means permits the inclusion of a fill line211, which forms a part of the alternate fill means, and a fluiddelivery line each of which communicates with the reservoir of thedevice.

Considering particularly FIGS. 11 and 15, the fluid dispensing assemblyof this latest form of the invention can be seen to comprise anelongated housing 60 having an internal chamber 62 and a two-partsupport 154 disposed within internal chamber 62 and extendinglongitudinally thereof. The stored energy means of the invention is hereprovided in the form of a generally cylindrically shaped, elongatedelastomeric member 66 of identical construction to that previouslydescribed.

Housing 60 comprises a cylindrically shaped central portion 60a andinlet and outlet end plates 60b and 156 respectively. Central section60a and end plates 60b and 156 may be constructed from any suitablerigid plastic material such as a polycarbonate and the end plates can beaffixed to the central section by any suitable means such as adhesivebonding or an appropriate sonic weldment. As before, end plate 60b isprovided with a vent port "V" for venting gases within the housing toatmosphere. Elastomeric member 66 is securely affixed proximate its endsto support 154 by means of suitable ring clamps 68 and 70 such asself-locking plastic panduit strips.

As best seen by referring to FIG. 15, support 154 is formed by a forwardsection 154a and a rearward section 154b which is integrally formed withend plate 60b. Support 154 is provided with an elongated receivingchamber 157 having an inner end wall portion 158 which is provided witha central counterbore 160 (FIG. 11). Wall 158 is also provided withfirst and second radially extending fluid passageways 162 and 164.Passageway 162 communicates proximate its central portion withcounterbore 160 and communicates at its end portions with a fluidreservoir 167 (FIG. 15) formed between elastomeric member 66 and theouter central surface of support 154. The extremities of passageway 164communicate with fluid reservoir 167 while the center portion thereofcommunicates with an inlet passageway 168, which, in turn, communicateswith a central bore 170 provided in end plate 156. End plate 156 is alsoprovided with an inlet passageway 172 which forms a part of a luer likeconnector 174 which is integrally formed with end plate 156.

As shown in FIG. 15, end wall or partition 158 of support 154 is alsoprovided with a pair of radially spaced, longitudinally extending fluidpassageways 176 and 178. The inboard end of each of these passagewayscommunicates with reservoir 167 while the outboard ends thereofcommunicate with novel flow control means for controlling fluid flowoutwardly of passageways 176. This flow control means here comprises anannular shaped filter 180 and an annular shaped rate control member 182.Member 182 overlays a generally annular shaped chamber 187 formed in endplate 156, which chamber, in a manner presently to be described,communicates with the fluid outlet port of the apparatus via bore 191.As best seen in FIG. 13, annular chamber 187 includes a multiplicity ofmicrochannels and grooves 187a which direct the flow of fluid toward anoutlet passageway 186 formed in end plate 156 (see also FIG. 11). Outletpassageway 186 communicates with a fluid delivery tube 190 one end ofwhich is received within a bore 191 formed in end plate 156. Theopposite end of tube 190 is connected to a conventional luer fitting192. A female luer cap 192a (FIG. 15) is mateable with fitting 192 toblock fluid flow outwardly of delivery tube 190.

Forming an important aspect of this latest form of the dispensing deviceis the provision of a first check valve means for controlling fluid flowtoward inlet passageway 162. This first valve means is here provided inthe form of a first valve assembly which includes a valve seat defininghousing 195 which has an internal valve seat 197 and an outwardlyextending hollow piercing cannula 199 (FIG. 11). Housing 195, which isclosely receivable within counterbore 160 formed in wall 158, houses agenerally spherical shaped rubber or silicone valve member 201 which isnormally held in sealing engagement with a seat 197 formed in housing195 by a biasing means shown here as a coil spring 204.

A second check valve means controls fluid flow between passageway 172and passageway 168. This second valve means which forms a part of thealternate fill means, comprises a valve member 200 which includes a bodyportion 200a, a neck portion 200b and an intermediate tapered shoulder200c. Check valve member 200 can be constructed from rubber, silicone,urethane and like materials. When reservoir 167 is filled, fluid underpressure within passageway 168 will maintain shoulder 200c of the valvemember in sealing engagement with the valve seat 207 formed in end plate156.

When the alternate fill means is used to fill reservoir 167 of thedispensing portion of the apparatus, a filling line assembly 210, whichincludes a fill line 211, is connected to luer like connector 174 sothat fluid under pressure can be introduced into passageway 172. Thisfluid under pressure will move valve 200 member inwardly causingshoulder 200c to move away from seat 207 thereby permitting fluid toflow past valve member body 200a, through a plurality ofcircumferentially spaced channels 209 formed in end plate 156 (see FIGS.11 and 13). Fluid will then flow into inlet passageway 168 to passageway164 to either fill or partially fill the reservoir 167. By way ofexample a dilluent could be introduced into reservoir 167 via thefilling line assembly 210 and an injectable drug could be introducedinto the reservoir using fill assembly 12.

When it is desired to fill or partially fill reservoir 167 with the fillassembly of the invention, the cover subassembly is, as before, removedfrom the container subassembly by pulling on pull-tab 42a and theadapter subassembly is then telescopically inserted into receivingchamber 157 in the manner shown in FIG. 15.

As the adapter subassembly approaches a seated position within thereceiving chamber 157, the piercing cannula 199 will pierce septum 24 ofthe container subassembly. Once a fluid flow path between the hollowcannula and the fluid reservoir 167 of the fluid dispensing device isthus created, a continued inward movement of the adapter subassembly 15will cause pusher rod 36 thereof to move plunger 26 forwardly of chamber18 to a position shown in FIG. 15. As plunger 26 is moved forwardly ofchamber 18, fluid contained within the chamber will flow through thehollow cannula and will move valve element 201 away from seat 197against the urging of spring 204. With the valve means open, the fluidwill flow into passageway 162 of partition wall 158 and then into fluidreservoir 167. As the fluid under pressure flows into reservoir 167,membrane 66 will be distended outwardly in the manner shown in FIG. 15wherein the central portion thereof is spaced from support 154. It is tobe noted that at the commencement of the fluid delivery step, spring 204will urge valve element 201 into sealing engagement with seat 197thereby maintaining reservoir 167 in a filled condition.

As before, locking means, including a flexible locking tab 154c, isprovided on support 154 to engage locking teeth 122 and 124 provided onadapter 15 in order to lock the adapter in position within housing 150after the filling step has been completed. A medicament label "L"surrounds housing 150 to identify the medicament contained within thereservoir 167.

Once distendable membrane 66 is distended to form fluid reservoir 167,the apparatus will remain in this filled condition until the outletpassageway of the fitting 192 is opened by the removal of female luer192a (FIG. 15). With the outlet passageway thus opened, the storedenergy means or membrane 66 will tend to return to a less distendedcondition causing fluid to flow outwardly of the apparatus viapassageway 176 and 178, through the flow control means 97, into annularchamber 187, and then outwardly through passageway 186 and into deliverytube 190.

Turning now to FIGS. 16 through 22, yet another embodiment of thepresent invention is there illustrated. This embodiment is similar inmany respects to the embodiment shown in FIGS. 1 through 9 and,accordingly like numbers have been used to identify like components. Theprimary difference between this last form of the invention and that ofFIGS. 1 through 9 is the design of the outlet, or forward portion of thedispensing assembly. More particularly, as best seen in FIG. 21, thisform of the invention includes alternate fill means for filling thefluid reservoir of the device. This alternate fill means includes aradially offset inlet, part of which includes check valve means forcontrolling fluid flow toward the reservoir 94 of the device. This checkvalve means is housed within a chamber 248 formed in the inboard end ofa luer like connector 250 which is connected to an end plate 252 andcomprises a valve member 254 having a body portion 254a, a neck portion254b and an intermediate shoulder portion 254c. Chamber 248 communicatesvia passageway 255a of manifold element 255 (FIGS. 16 and 21) with aninlet passageway 256 which is formed in end wall 260a of support 260 andwhich, in turn, communicates with reservoir 94 via annular passageway256a. Central support 160, which is virtually identical to support 64 ofthe embodiment shown in FIG. 4, is also provided with an end wallportion 260a having formed thereon radially extending passageways 90 and92 each of which communicates with reservoir 94. As before, the centralportion of passageway 92 communicates with a passageway 96, which, inturn, communicates with the flow control means of the invention. As bestseen in FIG. 21, an outlet passageway 263 interconnects the flow controlmeans with an outlet luer like connector 265 which forms an integralpart of end plate 252. Connector 265 is designed to receive a closurecap 267 which functions to block fluid flow through passageway 263.Similarly, inlet luer connector 250 is designed to lockably mate with alocking fill cap 270. Cap 270 includes circumferentially spaced lockingfins 270a which lockably mate with circumferentially spaced fins 270eprovided on fitting 250 (FIGS. 16, 17, and 21). With this arrangement,once cap 270 is connected to fitting 250, it will be securely locked inplace thereon and sealably close the inlet passageway thereof.

As best seen in FIG. 16, the flow control means of the present form ofthe invention comprises an assemblage made up of four disc-like waferswhich are mounted within a rate control chamber 271 formed in end wall260 of central support 260. Wafers 272 and 274 of the assemblagecomprise porous glass distribution frits while intermediate wafer 276comprises a filter member and intermediate wafer 278 comprises a ratecontrol member.

Filter member 276 can be constructed from a wide variety of materials,but a material comprising polysulfone sold by Gelman Sciences under thename and style of SUPOR has proven satisfactory for the purpose. Ratecontrol member 278 is preferably constructed from a thin film,polycarbonate material having extremely small flow apertures ablativelydrilled by an excimer laser ablation process. Both the orifice size andunit distribution can be closely controlled by this process. However, anumber of other materials can also be used to construct this permeablemember including metals, ceramics, plastics and glass. The rate controlC member can be specifically tailored to accommodate various deliveryregimens including low flow and intermediate flow conditions.

The apparatus of this last form of the invention, is used in the samegeneral manner as previously described to fill reservoir 94 either bymeans of the fill assembly or by means of the fill port or luer likefitting 250. When filling is accomplished using the alternate fillmeans, fluid is introduced into passageway 256 by exertion of fluidpressure on valve member 254 sufficient to move shoulder 254c away fromseat 250a of fitting 250 so that fluid can flow past valve member body254a, passageway 255a of manifold element 255, and through a pluralityof circumferentially spaced channels 280 formed in fitting 250 throughchamber 248, into passageway 255a of manifold 255 and then intopassageway 256 (FIG. 19). In this instance filling of the reservoir isaccomplished by a separate luer type fill fitting (not shown) and aseparate fill line (not shown). After the reservoir is filled, theseparate fill fitting is removed and replaced by a sealing closure 270(FIG. 21). Cap 270 includes circumferentially spaced locking fins 270awhich lockably mate with circumferentially spaced fins 270-1 provided onfitting 250. With this arrangement, once cap 270 is connected to fitting250, it will be securely locked in place thereon.

When it is desired to fill or partially fill reservoir 94 using the fillassembly rather than the alternate fill means, the fill assembly ismated with the fluid delivery assembly in the same manner as previouslydescribed, herein in connection with the embodiments of FIGS. 1 through15.

Referring next to FIGS. 23 through 29, still another form of theapparatus of the invention is there shown and generally designated by anumeral 300. Apparatus 300 is similar to that shown in FIGS. 1 through 9but uniquely comprises an in-line apparatus made up of two mainassemblies, namely a fluid dispensing assembly 301 and a fill assembly302 for use in filling the fluid reservoir of the dispensing assembly.Unlike the apparatus shown in FIG. 4, the fill assembly does not extendinto the tubular support portion of the fluid dispensing assembly, butrather remains in line with it as shown in FIG. 25. This enables theoverall diameter of the device to be smaller with the fluid dispensingassembly also being smaller and more compact. Dispensing assembly 301,the details of construction of which will presently be described, issimilar in some respects to the dispensing assemblies previouslydescribed herein and includes an elongated, tubular support or body 304,a stored energy means for forming in conjunction with support 304 afluid reservoir 306 for containing medicinal fluids to be controllablyinfused into a patient (FIG. 25) and a two-part housing includinggenerally cylindrically shaped first, elongated housing 308 whichcircumscribes both body 304 and the stored energy means and a generallyrectangularly shaped second, elongated hollow housing 310 which isconnected to housing 308. Housings 308 and 310 have outside diametersthat are substantially the same (see FIG. 25).

As best seen in FIGS. 25, the fill assembly portion 302 of the apparatuscomprises a container subassembly 314, an adapter subassembly 315, and acover subassembly 17, of the same general character as previouslydescribed and as shown in FIG. 6 or the drawings. As before, containersubassembly 314 includes a body portion 316, having a fluid chamber 318for containing an injectable fluid "F" and is provided with first andsecond ends 320 and 322. First end 320 is sealably closed by fluidoutlet means for permitting fluid flow from fluid chamber 318. Thisfluid outlet means is here provided in the form of a pierceable septumassembly 324. Septum assembly 324 is held securely in position byclamping ring 324a. As in the earlier described embodiments, fluiddisplacement means, shown here as a plunger 326 is telescopicallymovable within chamber 318 of container subassembly 314 from a firstlocation proximate end 322 to a second position proximate end 320 todisplace the fluid from the chamber and cause it to flow outwardly ofthe fluid outlet means.

Referring particularly to FIGS. 23 and 25, it can be seen that theadapter subassembly 315 comprises a hollow housing 330 having a firstopen end 332 and a second closed end 334. As indicated in FIG. 25,housing 330 is telescopically receivable within housing 310. Containersubassembly 314 is, in turn, telescopically receivable within open end332 of housing 330 in the manner shown in FIG. 25 so that the housingcan be moved from the first extended position shown in FIG. 24 to a vialencapsulation position wherein the vial resides within housing 330. Apusher means shown here as an elongated pusher rod 336 functions to moveplunger 326 within fluid chamber 318 from the first position to thesecond position. Pusher rod 336 has a first end 336a interconnected withclosure wall 334 and an opposite end 336b which engages plunger 326and-causes telescopic movement of the plunger within chamber 318 ofcontainer subassembly 314 as housing 330 is moved from the extendedposition into the vial encapsulating position.

Cover subassembly 17 of the fill assembly of this latest form of theinvention is substantially identical to that shown in FIG. 6 andincludes a spiral wound, frangible portion 42 having a first open end 44for telescopically receiving body portion 316 of container subassembly314 and a second closed end 46. Portion 42 initially circumscribes amajor portion of container subassembly 314 in the manner previouslydescribed and an integral pull tab 42a is provided to permit the spiralwound, frangible portion to be pulled from container subassembly 314 soas to expose a substantial portion of body 316. As best seen in FIG. 6,a medicament label 50 circumscribes spiral wound portion 42 and servesto prevent accidental unwinding of the spiral portion from the containersubassembly 314.

Turning once again to FIGS. 23 and 25, housing portion 308 of the fluiddispensing assembly 301 includes an internal chamber 312 within whichsupport 304 extends longitudinally. The stored energy means of theinvention is here provided in the form of a generally cylindricallyshaped, elongated elastomeric member 316 which is securely affixedproximate its ends to support 304 by means of suitable ring clamps 318and 320. A novel barrier member 321, the purpose of which will presentlybe described, is also affixed to support 314 by ring clamps 318 and 320.Disposed intermediate elastomeric member 316 and barrier member 321 is aunique, conformable, ullage-defining means, the nature and constructionof which will be described in connection with a description of theoperation of the apparatus.

As best seen by referring to FIG. 25, housing portion 310 is providedwith an end wall 310a which supports a hollow piercing cannula 325 whichextends into the interior housing portion 310. The fluid passageway 325aof hollow cannula 325 communicates with a fluid reservoir 306 via alongitudinally extending passageway 364a provided in support 304 andradially extending passageways 304b formed proximate the center ofsupport 304. Passageway 364a also communicates with flow control means327, the character of which will presently be described. Formed at theoutboard end of housing portion 308 is a tubular extension 329 having anoutlet passageway 329a which is in communication with the flow controlmeans 327. Extension 329 terminates in a luer-like connector portion 334for use in coupling the apparatus with an administration set or thelike. A closure cap 335 is also mateable with portion 334 for closingpassageway 329a.

The novel flow control means of the form of the invention shown in FIG.25 comprises an elongated, porous combination filter and rate controlelement 340 which is of a character well known in the art. Element 340can be constructed from a wide variety of materials, but a materialcomprising polysulfone sold by Gelman Sciences under the name and styleof SUPOR has proven satisfactory for the purpose. However, a number ofother materials can also be used to construct this element includingmetals, ceramics, cermet, plastics and glass.

In using the apparatus of the invention, with the fill assembly in thefilled configuration shown in FIG. 7, the cover subassembly is firstremoved from the container subassembly by pulling on pull-tab 42a. Thiswill cause the spiral portion 42 of the cover subassembly to tear awayfrom the container subassembly so that it can be separated from theforwardly disposed portion 52. Once the spiral wound portion 42 isremoved, cylindrical portion 52 can also be removed and discarded.Removal of the cover subassembly exposes the forward portion of thecontainer subassembly and readies the adapter subassembly forinterconnection with the fluid dispensing assembly 301.

Mating of the adapter subassembly 302 with the dispensing assembly 301is accomplished by telescopically inserting the exposed containerportion of the container subassembly 314 into the receiving chamber 310band pushing the assemblage forwardly of housing 310. As the adaptersubassembly approaches a seated position within receiving chamber 310b,the piercing cannula 325 will pierce septum 324 of the containersubassembly. Once the fluid flow path between the hollow cannula and thefluid reservoir 306 of the fluid dispensing device is thus created viapassageways 304a and 304b, a continued inward movement of the adaptersubassembly will cause pusher rod 336 to move plunger 326 forwardly ofchamber 318. As plunger 326 is moved forwardly of chamber 318, fluidcontained within the chamber will flow through the hollow cannula intopassageway 304a of support 304 and then into fluid reservoir 306 viapassageways 304b. As the fluid under pressure flows into reservoir 318,it will act on barrier member 321 causing the conformable ullagedefining means to distend elastomeric member 316 outwardly in the mannershown in FIG. 25. Rings 318 and 320, which are in clamping engagementwith elastomeric and barrier member 316 and 321, function to seal themember against the end portions of the support and prevent leakage offluid therebetween. As the distendable membrane expands outwardly, thedisplaced air within housing 308 will be vented to atmosphere via ventmeans "V" provided in the housing.

As earlier discussed, elastomeric member 316 can comprise a single filmlayer or can be made up of a laminate construction. Materials suitablefor constructing this member are previously defined herein. Barriermember 321 can also be constructed of various elastomeric materials suchas latex rubber, natural rubber and other homopolymers and copolymers.Preferably, the material candidates for use in constructing the barriermembrane should be drug compatible since the membrane will typically becontact with the drug containing fluid that is introduced into thereservoir.

The important conformable ullage defining means here comprises aconformable ullage 343 which uniquely conforms to the shape of thedistendable membrane, as the membrane tends to return to its lessdistended configuration. Conformable ullage 343 can be constructed as adeformable mass from a number of materials such as various types ofgels, foams, fluids and soft elastomers. In some instances theconformable ullage may comprise an integral conforming mass. In otherinstances, such as when a gel or fluid is used as the ullage medium, theencapsulation barrier member 321 is, of necessity, used to encapsulatethe ullage medium.

To further understand the importance of the conformable ullage-definingmeans of the invention, it must be appreciated that the materialssuitable for constructing the stored energy means or elastomeric member316 must possess certain specific physical characteristics in order tomeet the performance requirements of the fluid delivery apparatus. Forexample, depending on the end use of the device, the elastomeric membermust have good memory characteristics under conditions of highextension, good resistance to chemical and radiological degradation andappropriate gas permeation characteristics. Once an elastomeric materialis chosen that will optimally meet the desired performance requirementsof the fluid delivery device, there are still limitations to the levelof refinement of the delivery tolerances that can be achieved using therigid configuration of support member 304. These refinements are dueprimarily to the inability of the elastomeric member to conform to theshape of the support member 304 near the end of the fluid deliverycycle. This nonconformity can lead to extended delivery rate tail offand higher residual problems that are undesirable when extremelyaccurate delivery is required. For example, when larger volumes of fluidare to be delivered, the tail-off volume represents a smaller portion ofthe fluid amount delivered and, therefore, exhibits much less effect onthe total fluid delivery profile. However, as is here the case, in verysmall dosages, the tail-off volume becomes a larger portion of the totalvolume. This places physical limits on the range of delivery profilesthat can acceptably be accommodated by the earlier describedconstructions as shown in FIGS. 1 through 22.

The apparatus of the invention illustrated in FIGS. 23 through 28provides a unique and novel improvement over the apparatus shown inFIGS. 1 through 22. More particularly, this novel embodiment of theinvention includes the previously identified conformable ullage 343 thatcan be constructed from various materials that will elegantly satisfythe more stringent delivery tolerance requirements of the device, whileat the same time effectively overcoming the limitations of materialsselection encountered in devices embodying the constructions describedin connection with the earlier discussed forms of the invention.

The unique characteristics of the conformable ullage of this latest formof the invention permits the ullage to be located above the fluidreservoir in relation to support 304. This permits a much smallerportion of the pressure-deformation curve to be used, thus enabling thestored energy membrane to undergo less deformation during the fluiddelivery process. Less deformation of the stored energy membrane, inturn, minimizes the changes in the linearity of the resulting fluiddelivery profile. Further, because the small portion of thepressure-deformation curve that is used can be taken from a lowerelongation level, the viscoelastic effect is reduced. The viscoelasticeffect reduces the level of stored energy in the membrane over time,which translates into lower rates of energy membrane stress relaxationover time. This is a most important performance design factor fordevices requiring prolonged shelf life having extended deliveryprofiles.

Turning once again to FIG. 25, once barrier member 321 and distendablemember 316 are distended in the manner shown in FIG. 24 to form fluidreservoir 306, the apparatus will remain in this filled condition untiloutlet passageway 329a of the luer-like connector assembly 329 is openedto fluid flow. When the outlet passageway 329a is opened, the storedenergy means or elastomeric member 316 will tend to return to a lessdistended condition causing a pressure to be exerted on conformableullage 343. Ullage 343 will conform to the shape of the distendablemember as it returns to the less distended configuration and will actupon barrier member 321 in a manner to cause the fluid contained withinthe reservoir to flow outwardly of the apparatus via passageways 304b,passageway 304a, through the flow control means 327, and then outwardlyof the device through passageway 329a.

Materials suitable for use in constructing housing portions 308 and 310and support 304 include metals, rubber or plastics that are compatiblewith the liquids they contact and are preferably non-allergenic typematerials. Suitable sources of supply of the materials are as previouslydefined herein.

In order to securely lock the adapter subassembly 315 with thedispensing assembly 301 after the reservoir has been filled, novellocking means are provided. As best seen in FIG. 24, the locking meanshere comprise a series of locking teeth 345. These locking teeth areconstructed so that they will slide under a flexible locking tab 347,which is provided proximate the entrance of receiving chamber 310b, asthe adapter subassembly is urged inwardly of receiving chamber (FIG.23). However, once the adapter subassembly has reached its fully forwardposition, locking tab 347 will engage one of the teeth 345 andeffectively prevent removal of housing 60 of the adapter subassemblyfrom passageway 310a. With this novel construction, once the reservoir306 has been filled with the fluid "F" contained in the containersubassembly, the adapter assembly cannot be removed from the fluiddispensing device and, thereby preventing system adulteration.

Having now described the invention in detail in accordance with therequirements of the patent statutes, those skilled in this art will haveno difficulty in making changes and modifications in the individualparts or their relative assembly in order to meet specific requirementsor conditions. Such changes and modifications may be made withoutdeparting from the scope and spirit of the invention, as set forth inthe following claims.

I claim:
 1. A fluid delivery apparatus comprising:(a) a fluid deliveryassembly comprising:(i) a support assembly including:a. an elongatedbody having first and second communicating fluid passageways; and b. afluid inlet means for permitting fluid flow into said first fluidpassageway formed in said elongated body portion; and (ii) stored energymeans comprising an elongated tubular shaped elastomeric membercircumscribing said elongated body and sealably connected proximate itsends to said elongated body, said elastomeric member having a centralportion overlaying said second fluid passageway, said central portion ofsaid elastomeric member being distendable by fluid flowing through saidfirst and second fluid passageways from a first position in proximitywith said elongated body to a second position where internal stressesare formed in said elastomeric member tending to return it to a lessdistended configuration; and (iii) a first housing enclosing saidsupport assembly and said stored energy means; and (b) a fill assemblyinterconnected with said fluid delivery assembly comprising:(i) a secondhousing connected in line with said first housing; (ii) containerassembly telescopically receivable within said second housing, saidcontainer assembly including:a. a container having a body portion, afluid chamber, and first and second open ends; b. fluid outlet meansassociated with said container for permitting fluid flow from saidcontainer, said outlet means being capable of communicating with saidfluid inlet means of said support assembly to permit fluid flow intosaid first fluid passageway of said elongated body; and c. fluiddisplacement means for causing fluid to flow toward said outlet means;and (iii) an adapter assembly telescopically receivable within saidsecond housing, said adapter assembly comprising a hollow housing havinga first open end for telescopically receiving a part of said bodyportion of said container of said container assembly and including asecond end.
 2. An apparatus as defined in claim 1 in which said fluidinlet means of said support assembly comprises a hollow cannula and inwhich said fluid outlet means of said container comprises a pierceableseptum.
 3. An apparatus as defined in claim 1 in which said fluiddisplacement means comprises a plunger telescopically movable withinsaid container from a first location to a second location and in whichsaid hollow housing of said adapter assembly further includes pushermeans for engagement with said plunger of said container assembly tomove said plunger within said container between first and secondlocations.
 4. An apparatus as defined in claim 1 in which said fluiddelivery means further includes a conformable mass disposed between saidelastomeric member and said elongated body, said conformable masssubstantially conforming to the shape of the elastomeric member as saidmember tends to return to a less distended configuration.
 5. Anapparatus as defined in claim 1 in which said fill assembly furtherincludes a cover assembly comprising a cover having a first open end fortelescopically receiving a part of said body portion of said containerof said container assembly and a second end, said cover being removablefrom said container to expose said closure means.
 6. A apparatus asdefined in claim 1 in which said fluid delivery assembly furtherincludes a first elongated hollow housing having walls defining aninternal chamber, said elongated body portion of said support assemblyextending into said internal chamber.
 7. An apparatus as defined inclaim 6 in which said elongated hollow housing is provided with a fluidoutlet, and in which said fluid delivery means further includes a flowcontrol means for controlling fluid flow between said second fluidpassageway formed in said elongated housing of said support assembly andsaid outlet of said elongated housing.
 8. An apparatus as defined inclaim 6 in which said support assembly of said fluid delivery assemblyfurther includes a second elongated hollow housing having a receivingchamber, said adapter assembly being receivable within said receivingchamber.
 9. An apparatus as defined in claim 8 in which said first andsecond elongated hollow housings having substantially identical outsidediameters.
 10. A fluid delivery apparatus comprising:(a) a fluiddelivery assembly comprising:(i) an elongated first housing of a firstdiameter having walls defining an internal chamber, one of said wallshaving an outlet passageway; (ii) a support assembly enclosed withinsaid first housing, said support assembly including:a. an elongated bodyhaving an end wall portion and having first and second communicatingfluid passageways; and b. a hollow cannula connected to said end wallportion, said hollow cannula being in communication with said first andsecond fluid passageways; and (iii) an elongated tubular shapedelastomeric member circumscribing a substantial portion of saidelongated body and connected proximate its ends to said elongated body,said elastomeric member having a central portion disposed within saidinternal chamber of said first housing and overlaying said second fluidpassageway, said central portion of said elastomeric member beingdistendable by fluid flowing through said first and second fluidpassageways from a first position in proximity with said elongated bodyto a second position; and (b) a fill assembly interconnected with saidfluid delivery assembly comprising:(i) a second housing connected inline with said first housing; (ii) a container assembly telescopicallyreceivable within said second housing, said container assemblyincluding:a. a container having a body portion, a fluid chamber, andfirst and second open ends; b. closure means for sealably closing saidfirst end of said container, said closure means comprising a pierceableseptum pierceable by said hollow cannula; c. a plunger telescopicallymovable within said container from a first location proximate said openend to a second spaced apart location to cause fluid flow into saidhollow cannula; and d. pusher means for engagement with said plunger ofsaid container assembly to move said plunger within said containerbetween first and second locations; and (iii) an adapter assemblytelescopically receivable within said second housing, said adapterassembly comprising a hollow housing having a first open end fortelescopically receiving a part of said body portion of said containerof said container assembly and including a second end.
 11. An apparatusas defined in claim 10 in which said fluid delivery assembly furtherincludes flow control means for controlling fluid flow toward saidoutlet passageway of said elongated housing.
 12. An apparatus as definedin claim 11 in which said flow control means include flow rate controlmeans for precisely controlling the rate of flow of fluid through saidoutlet passageway of said elongated housing.
 13. An apparatus as definedin claim 12 in which said flow rate control means comprises a permeableporous member.
 14. An apparatus as defined in claim 12 in which saidflow rate control means comprises a rate control element having laserdrilled apertures therethrough.
 15. An apparatus as defined in claim 12in which said fluid delivery assembly further includes valve means forcontrolling fluid flow from said hollow cannula toward said firstpassageway formed in said end wall portion.
 16. A fluid deliveryapparatus comprising:(a) a fluid delivery assembly comprising:(i) asupport assembly including:a. an elongated body having first and secondcommunicating fluid passageways; and b. fluid inlet means for permittingfluid flow into said first and second fluid passageways formed in saidelongated body; and (ii) an elongated tubular shaped elastomeric membercircumscribing said elongated body and connected proximate its ends tosaid elongated body, said elastomeric member overlaying said secondfluid passageway, said central portion of said elastomeric member beingdistendable by fluid flowing through said first and second fluidpassageways to establish internal stresses with said elastomeric membertending to return said elastomeric member to urge a less distendedconfiguration, said elastomeric member being distended from a firstposition in proximity with said elongated body to a second position todefine in cooperation with said elongated body, a chamber; and (iii)ullage defining means for defining an ullage within said chamber definedby said elastomeric member and said elongated body; (b) a fill assemblyinterconnected in line with said fluid delivery assembly comprising:(i)a container assembly including:a. a container having a body portiondefining, a fluid reservoir having a fluid outlet; b. closure means forclosing said fluid outlet of said container; and c. a fluid displacementmeans for displacing fluid within said reservoir to cause fluid flowtoward said outlet of said reservoir; and (ii) an adapter assemblymateable with said support assembly, said adapter assembly comprising ahollow housing having a first open end for telescopically receiving apart of said body portion of said container of said container assemblyand including a second end.
 17. An apparatus as defined in claim 16 inwhich said ullage defining means of said fluid delivery assemblycomprises a conformable mass conformable to said elastomeric member assaid member tends to return to a less distended configuration.
 18. Anapparatus as defined in claim 16 in which said fluid delivery assemblyfurther includes a second elongated hollow housing having a receivingchamber, said adapter assembly being receivable within said receivingchamber.
 19. An apparatus as defined in claim 16 in which said fluidinlet means of said support assembly comprises a hollow cannula and inwhich said fluid outlet of said fluid reservoir of said containercomprises a pierceable septum.
 20. An apparatus as defined in claim 17in which said fluid displacement means comprises a plungertelescopically movable within said container from a first location to asecond location and in which said hollow housing of said adapterassembly further includes pusher means for engagement with said plungerof said container assembly to move said plunger within said containerbetween first and second locations.